-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, LAN4wHtFrzhnEBVxLLzXYLt+CgsfjHRLFU7HaFtb3BbPDgmjz2VAlL9oWOJEE4aJ I4jh5sWs3hVeZyRMw0f/mQ== 0001157523-09-005705.txt : 20090806 0001157523-09-005705.hdr.sgml : 20090806 20090806083516 ACCESSION NUMBER: 0001157523-09-005705 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090806 DATE AS OF CHANGE: 20090806 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NPS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000890465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 870439579 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23272 FILM NUMBER: 09990031 BUSINESS ADDRESS: STREET 1: 550 HILLS DRIVE CITY: BEDMINSTER STATE: NJ ZIP: 07921 BUSINESS PHONE: (908) 450-5300 MAIL ADDRESS: STREET 1: 550 HILLS DRIVE CITY: BEDMINSTER STATE: NJ ZIP: 07921 8-K 1 a6023499.htm NPS PHARMACEUTICALS, INC. 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

August 6, 2009
Date of Report (Date of earliest event reported)

NPS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)


Delaware

0-23272

87-0439579

(State or other jurisdiction of
incorporation)

(Commission File Number)

 

(I.R.S. Employer

Identification Number)

550 Hills Drive, 3rd Floor
Bedminster, NJ 07921
(Address of principal executive offices)

(908) 450-5300
(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


ITEM 2.02.          Results of Operations and Financial Condition.

On August 6, 2009, we issued a press release announcing our operating results for the second quarter of 2009.  The text of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information in Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01.          Financial Statements and Exhibits.

(c)    Exhibits

 

Exhibit No.

Description

99.1 Press Release dated August 6, 2009.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:

August 6, 2009

NPS PHARMACEUTICALS, INC.

 

 

 

 

By:

/s/ ANDREW RACKEAR

Andrew Rackear

Senior Vice President, General Counsel and
Secretary


EXHIBIT INDEX

Exhibit
Number

  Description
99.1 Press Release issued by NPS Pharmaceuticals, Inc. on August 6, 2009.

EX-99.1 2 a6023499ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

NPS Pharmaceuticals Reports Second Quarter 2009 Financial Results; Two Phase 3 Registration Programs Continue to Advance on Stated Timelines

-- Conference call today at 9:00 AM ET --

BEDMINSTER, N.J.--(BUSINESS WIRE)--August 6, 2009--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today reported its financial results for the second quarter of 2009. The company reported net income of $2.6 million, or $0.05 per diluted share, for the second quarter of 2009 as compared to net income of $1.2 million, or $0.03 per diluted share, for the second quarter of 2008.

The company’s cash, cash equivalents and short- and long-term investments totaled $92.0 million at June 30, 2009 versus $106.1 million at December 31, 2008. NPS used $8.5 million in cash during the second quarter of 2009 (excluding changes in the carrying value of auction-rate securities or ARS investments). The company’s cash burn guidance for 2009 remains unchanged at $55 to $65 million and, consistent with prior periods, excludes potential changes in the estimated fair value of the company’s ARS investments.

“We continue to be proactive in managing the business to ensure we deliver on our stated objectives,” said Francois Nader, M.D., president and chief executive officer of NPS Pharmaceuticals. “Our timelines for completing enrollment in the STEPS and REPLACE studies before the end of the first quarter of 2010 are on track as are our preparations for regulatory review and commercialization of these product candidates. In addition, we are aggressively managing our burn and our cash position remains strong. We are actively evaluating multiple opportunities to further strengthen our balance sheet and the financing facility we announced today adds to our potential suite of options for raising new capital.”


Product Pipeline Update

GATTEX™ (teduglutide)

  • NPS continues to expect STEPS to complete enrollment before the end of the first quarter of 2010. NPS and its partner, Nycomed, have secured health authority clearance in all 10 countries with STEPS study sites and expects substantially all study sites to be actively screening patients before the end of the third quarter of 2009. STEPS is an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.
  • The STEPS 2-year extension study (STEPS 2) is on track to begin during the third quarter of 2009. The extension study will enroll patients who have completed 24-weeks of GATTEX therapy and elect to enter the open-label long-term study for up to an additional 24 months. The company’s partner, Nycomed, has opted to support the extension study on a collaborative basis and the companies will share 50% of external clinical trial expenses.
  • Clinical investigators presented new data from three sub-studies in patients with SBS who received GATTEX™ during the completed 24-week, placebo-controlled Phase 3 clinical trial at the 2009 Digestive Disease Week or DDW conference. The presentations showed that GATTEX enhances intestinal mass and function.
  • Preclinical activities evaluating teduglutide in pediatric indications and in chemotherapy-induced gastrointestinal mucositis continue to advance.

NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)

  • NPS continues to expect to complete enrollment in REPLACE before the end of the first quarter of 2010. NPS has secured health authority clearance in all seven countries with REPLACE study sites. The company expects substantially all study sites will be actively screening patients before the end of the third quarter of 2009. REPLACE is a Phase 3 registration study evaluating NPSP558 for the treatment of hypoparathyroidism in adults. NPS believes positive results from REPLACE will enable it to seek U.S. marketing approval for NPSP558 for patients with hypoparathyroidism.

Financial Results

Revenues

Revenues are comprised of royalties, product sales, and milestones and license fees.

NPS earns royalties on (i) Amgen’s sales of Sensipar® (cinacalcet HCl), (ii) Nycomed’s sales of Preotact® (parathyroid hormone 1-84 [rDNA origin] injection), (iii) Kyowa Kirin’s sales of REGPARA® (cinacalcet HCl) in Japan, and (iv) Ortho-McNeil-Janssen’s sales of Nucynta™ (tapentadol). Royalty revenue grew to $22.8 million for the second quarter of 2009, versus $17.5 million for the second quarter of 2008, as follows:

In millions   Second Quarter
2009   2008
Royalty:
Sensipar $19.3 $14.9
Preotact 2.4 2.2
REGPARA 0.9 0.4
Nucynta 0.2   --
Total $22.8   $17.5

The company’s royalty rights related to Sensipar and Preotact currently secure non-recourse debt. At June 30, 2009, the outstanding principal balance on the non-recourse debt secured by the company’s Sensipar royalties was $228.2 million. After repayment of the debt and interest, Sensipar royalties will return to NPS. When Preotact royalty payments exceed two and one-half times the amount of advanced principal, the royalties revert to NPS.

NPS earned a $2.2 million milestone during the second quarter of 2009 related to Preotact achieving certain sales levels during the quarter.

NPS recognized license fee revenue related to the company’s September 2007 agreement with Nycomed for GATTEX of $624,000 for the second quarter of 2009 versus $9.5 million for the second quarter of 2008. These amounts pertain to the up-front license fee received in 2007, which NPS initially recorded as deferred revenue.

Research and development

Research and development expenses were $6.4 million for the second quarter of 2009 versus $4.0 million for the second quarter of 2008. The increase in research and development expense was due to the advancement of the company’s registration programs for GATTEX in short bowel syndrome and NPSP558 in hypoparathyroidism.

General and administrative

General and administrative expenses were $5.0 million for the second quarter of 2009 versus $3.1 million for the second quarter of 2008. The change in general and administrative expense was largely due to credits for legal fees reimbursed from the company’s insurance carriers that positively affected the second quarter of 2008.


Interest expense

Second quarter interest expense was $11.8 million for 2009 versus $15.7 million for 2008. The decrease was primarily due to lower interest expense associated with the company’s non-recourse debt. With the exception of $50 million of the company’s convertible notes due in 2014, all of the company’s outstanding debt is non-recourse and is secured by its Sensipar and Preotact royalties.

Loss on investments

The company’s auction-rate securities or ARS investments have experienced failed auctions since the latter part of 2007 due to liquidity issues in the global credit and capital markets. While all of the company’s ARS continue to pay interest, the severity and the duration of the decline in fair value have resulted in the company recognizing “other than temporary” changes in the fair value of its ARS investments. There was no impairment charge in the second quarter of 2009 versus an impairment charge of $456,000 in the second quarter of 2008.

Cash and investments

At June 30, 2009, the company’s cash, cash equivalents, and short- and long-term investments totaled $92.0 million compared to $106.1 million at December 31, 2008. Included in these amounts are ARS investments with an estimated fair value of $8.3 million at June 30, 2009 and $8.8 million at December 31, 2008. The principle value of these ARS investments is $29.7 million. NPS has classified its ARS investments as non-current assets within its balance sheets.

Conference Call Information

NPS will host a conference call beginning today at 9:00 am Eastern Time. To participate in the conference call, dial (866) 800-8649 and use passcode 43462149. International callers may dial (617) 614-2703, using the same passcode. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the NPS website, http://www.npsp.com.

For those unable to participate in the live call, a replay will be available at (888) 286-8010, with passcode 26612097, until midnight ET, August 19, 2009. International callers may access the replay by dialing (617) 801-6888, using the same passcode. The webcast will also be available through the NPS website for the same period.


About NPS Pharmaceuticals

NPS Pharmaceuticals is developing new treatment options for patients with rare gastrointestinal and endocrine disorders. The company is currently conducting two Phase 3 registration studies. Teduglutide, a proprietary analog of GLP-2, is being evaluated as GATTEX™ in a Phase 3 registration study known as STEPS for intestinal failure associated with short bowel syndrome and in preclinical development for gastrointestinal mucositis and other pediatric indications. NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) is being evaluated in a Phase 3 registration study known as REPLACE as a hormone replacement therapy for hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Kirin, Nycomed, and Ortho-McNeil-Janssen Pharmaceuticals. Additional information is available at http://www.npsp.com.

“NPS” and “NPS Pharmaceuticals” are the company’s registered trademarks. Preotact® is the company’s registered trademark in the U.S. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to the company’s business include, but are not limited to, the risks associated with any failure by the company to successfully complete its preclinical and clinical studies within the projected time frames or not at all, the risk of not gaining marketing approvals for GATTEX and NPSP558, the risks associated with the company’s strategy, the risks associated with the company’s auction-rate securities, as well as other risk factors described in the company’s periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information.

(Financial statements to follow)


NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

         
 
Three Months Ended Six Months Ended
June 30, June 30,
2009   2008 2009   2008
 
Revenues:
Royalties $22,827

$17,493

$37,235

$30,191

Product sales 8 -- 8 1,684
Milestones and license fees 2,814 9,466 4,735 20,264
Total revenues 25,649 26,959 41,978 52,139
 
Costs and expenses:
Cost of goods sold -- -- -- 1,350
Cost of royalties -- 1,612 -- 2,985
Cost of license fees 123 1,919 481 3,839
Research and development 6,427 3,998 12,259 8,855
General and administrative 4,981 3,096 9,534 13,688
Total operating expenses 11,531 10,625 22,274 30,717
Operating income 14,118 16,334 19,704 21,422
 
Other (expense) income:
Interest income 400 975 1,000 2,821
Interest expense (11,800) (15,671) (27,491) (32,616)
Loss on impairment of marketable investment securities -- (456) (2,206) (3,909)
Other (expense) income, net (101) (76) (140) 295
Total other expense, net (11,501) (15,228) (28,837) (33,409)
Income (loss) before income tax benefit 2,617 1,106 (9,133) (11,987)
 
Income tax benefit -- (97) (1,014) (97)
Net income (loss) $2,617 $1,203 ($8,119) ($11,890)

Net income (loss) per common and potential common share:

Basic $0.05 $0.03 ($0.17) ($0.25)
Diluted $0.05 $0.03 ($0.17) ($0.25)
Weighted average common and potential common share:
Basic 48,017 47,670 47,988 47,559
Diluted 48,034 47,744 47,988 47,559

NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

    June 30,   December 31,
2009 2008
Assets:
Cash, cash equivalents and current marketable investment securities $83,670 $97,380
Current restricted cash and cash equivalents 9,765 37,016
Account receivable 24,226 25,406
Litigation settlement receivable -- 16,000
Other current assets 3,101 2,694
Equipment, net 395 285
Marketable investment securities, less current portion 8,343 8,752
Debt issuance costs, net 4,295 5,158
Other long-term assets 1,696 1,486
Goodwill 9,429 9,429
Total assets $144,920 $203,606
 
Liabilities and Stockholders’ Deficit:
Current liabilities $40,415 $81,889
Convertible notes and capital lease obligation 50,000 50,014
Non-recourse debt, less current portion* 255,200 268,277
Other long-term liabilities 19,179 18,512
Total liabilities 364,794 418,692
 
Common stock and additional paid-in capital 691,723 689,994
Accumulated other comprehensive income (loss) 1,402 (200)
Accumulated deficit (912,999) (904,880)
Total stockholders' deficit (219,874) (215,086)
Total liabilities and stockholders' deficit $144,920 $203,606
 
* Non-recourse debt secured by Sensipar® and Preotact® royalty revenue

CONTACT:
NPS Pharmaceuticals, Inc.
Susan Mesco, 908-450-5516
smesco@npsp.com

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